Lubna Rao

Dynamic and detail-oriented medical writer with a comprehensive background in medical writing, clinical research, and pharmacovigilance. Experienced in leading complex projects,

mentoring team members, and representing the Medical Writing department. Skilled in advising clients on data presentation strategies and ensuring client objectives are met while maintaining high-quality standards and compliance with regulatory guidelines. Committed to continuous professional development and contributing to cross-functional team success.

I have about 3 years of experience in the medical writing domain. During my tenure with a global CRO, I was able to lead multiple clinical as well as safety documents. Some of the documents I have contributed to includes PBRERS/PSURS, PADERS, CSR, DSUR, patient safety narratives, lay protocol synopsis, etc.

I have gained in depth understanding of FDA, ICH, and GVP guidelines. I actively participate in mentoring freshers as well as my peers on software or company processes. I am a strong team player but step up to leadership roles and opportunities.

For my contributions I was recognised for'Driving India's Mission and Vision'. I am a professional who is dedicated to continuous learning.

I hold a master's degree in Pharmacy with focus on Pharmacy Practice. This course has allowed me to gain knowledge regarding clinical research, pharmacovigilance, therapeutics, pharmacokinetics, and international safety and clinical regulations. My final project thesis ‘Developing simulated PBPK model of Valproic acid’ was accepted to be published in a tier 2 journal.